UNDER BUTTOCKS DRAPE

Drape, Surgical

INTERNATIONAL MEDSURG CONNECTION, INC.

The following data is part of a premarket notification filed by International Medsurg Connection, Inc. with the FDA for Under Buttocks Drape.

Pre-market Notification Details

Device IDK042893
510k NumberK042893
Device Name:UNDER BUTTOCKS DRAPE
ClassificationDrape, Surgical
Applicant INTERNATIONAL MEDSURG CONNECTION, INC. PO BOX 100624 Cudahy,  WI  53110
ContactTeodoro Santiago
CorrespondentTeodoro Santiago
INTERNATIONAL MEDSURG CONNECTION, INC. PO BOX 100624 Cudahy,  WI  53110
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-19
Decision Date2005-03-11
Summary:summary

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